Cyber Resilience Act (CRA)
The Cyber Resilience Act (CRA) represents a paradigm shift for machinery manufacturers, treating cybersecurity as a fundamental safety requirement. It applies to any "product with digital elements" connected to a device or network. For North American exporters, this means if your machine has an IoT sensor, a Wi-Fi module, or even a simple remote diagnostic port, it now falls under this regulation. You can no longer just secure the physical machine; you must secure its digital footprint.
Under the CRA, cybersecurity must be integrated from the design phase—a concept known as "security by design." Your Technical File must now include a cybersecurity Risk Assessment and a Software Bill of Materials (SBOM) to track vulnerabilities. Furthermore, manufacturers are obligated to provide security updates and report active vulnerabilities for the expected lifetime of the product (often up to 5 years).
Compliance is linked directly to the CE Mark. Without meeting CRA standards, you cannot legally affix the CE mark or complete your Declaration of Conformity (DoC). While most standard machinery will allow for Self-Certification, critical digital components may require assessment by a Notified Body. Failure to comply can result in massive fines and immediate withdrawal of your products from the EU market.
